Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490282
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2007-06-21
Brief Title:
A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to use computed tomography CT scans to measure and guide your radiation therapy Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy Researchers also want to see if magnetic resonance imaging MRI scanning can detect certain changes in the tumor any earlier than with standard tests
Detailed Description:
The Study Scans and Tests
IMRT is a type of 3-dimensional 3-D radiation therapy that can focus radiation beams directly on the tumor itself In this study the IMRT is given using a standard radiation machine ExaCT machine that has a CT scanner attached to it This machine is commonly used in patients with head and neck cancer It gives the same radiation treatment as most of the other machines at M D Anderson However in addition to giving radiation treatments it can also perform CT scans while the patient is in the same position on the treatment table before the radiation therapy is given
For this study your standard of care daily CT scans will be used to help researchers adjust participants radiation therapy if necessary on a weekly basis In particular the changes in normal tissue that are being studied are any changes in the salivary glands An additional research related MRI scan will also be performed in this study but the MRI scan will not be used to adjust participants therapy Researchers want to learn if MRI scanning may be able to help doctors in the future to adjust someones treatment based on changes in a tumor its features and size in response to radiation
Enrollment in the Study
If you agree to take part in this study you will receive IMRT according to the standard schedule over 6 - 7 weeks You will sign a separate consent form for the IMRT and the procedure and its risks will be explained to you at that time
CT Scans
During this study you will have a standard of care CT scan right before each IMRT treatment over a 6-7 week period of time depending on the exact schedule your doctor decides would be best for your treatment These CT scans are standard of care are used to make sure your treatment is being aimed properly and would be performed whether you are participating on this trial or not Once you are set up on the treatment table and are ready for radiation therapy the table will be turned around and the CT scan will be performed After the CT scan which should take about 5-8 minutes the table will be turned back around to the original position and the radiation treatment will be given to you In total about 30-33 CT scans will be performed for this study depending on the exact number of treatments the doctor decides would be best for your therapy
Routine MRI Scans
Routine MRI scans of your head and neck will be performed before treatment at Week 1 and after treatment sometime during Weeks 12-14 These scans may be used for routine treatment planning and checking the status of the disease
Study-Related MRI Scan
An additional MRI scan will be done halfway through treatment during Week 3 This MRI scan will be used to help researchers see if MRI scanning may be able to help doctors in the future to adjust someones treatment based on changes in a tumor its features and size in response to radiation In 15 participants a repeat baseline study-related MRI scan will be done 48 hours to 1 week following the first routine MRI scan
Modified Barium Swallow
Your swallowing function will be tested with a special type of x-ray called a modified barium swallow MBS During the test you will eat and drink foods and liquids mixed with a contrast chemical called barium that will make your throat more visible in the x-rays A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat
MBS will be performed before you start radiation therapy 4-6 months after the end of radiation therapy and during your routine follow-up visits 12 months plus or minus 2 months and 24 months plus or minus 3 months
Saliva Testing
One reason IMRT is being used is to try to protect your parotid glands the largest of the salivary glands from receiving too much radiation To check this a study-related saliva test will be done For this test the amount of saliva your parotid glands create will be measured before treatment within 7 days before Week 1 and at the last week of treatment during Week 6 or 7 Do not eat or drink anything or put anything in your mouth for 1 hour before the saliva collections You will be asked to let your saliva collect in your mouth for 5 minutes and then spit into a cup After that you will be given a mild citric acid solution like lemon juice to put in your mouth You will let the saliva collect in your mouth for 5 minutes and then spit in a cup Saliva testing will be performed under a separate protocol LAB07-0050
Length of Study
If the disease gets worse or intolerable side effects occur you will be taken off this study
Follow-Up Visits
At some time between Weeks 22 and 24 then every 3-4 months for up to 2 years after the last IMRT you will return for follow-up visits The amount of saliva your parotid glands create will be measured 6 weeks after radiation therapy 4-6 months after radiation therapy 1 year plus or minus 2 months after radiation therapy and 2 years plus or minus 3 months after radiation therapy
This is an investigational study The ExaCT machine is FDA approved for use in IMRT in patients with head and neck cancer Researchers are using this standard of care CT Scan for routine quality assurance to make sure your treatment is given correctly Up to 45 patients will take part in this study All will be enrolled at M D Anderson
IMRT is a type of 3-dimensional 3-D radiation therapy that can focus radiation beams directly on the tumor itself In this study the IMRT is given using a standard radiation machine ExaCT machine that has a CT scanner attached to it This machine is commonly used in patients with head and neck cancer It gives the same radiation treatment as most of the other machines at M D Anderson However in addition to giving radiation treatments it can also perform CT scans while the patient is in the same position on the treatment table before the radiation therapy is given
For this study your standard of care daily CT scans will be used to help researchers adjust participants radiation therapy if necessary on a weekly basis In particular the changes in normal tissue that are being studied are any changes in the salivary glands An additional research related MRI scan will also be performed in this study but the MRI scan will not be used to adjust participants therapy Researchers want to learn if MRI scanning may be able to help doctors in the future to adjust someones treatment based on changes in a tumor its features and size in response to radiation
Enrollment in the Study
If you agree to take part in this study you will receive IMRT according to the standard schedule over 6 - 7 weeks You will sign a separate consent form for the IMRT and the procedure and its risks will be explained to you at that time
CT Scans
During this study you will have a standard of care CT scan right before each IMRT treatment over a 6-7 week period of time depending on the exact schedule your doctor decides would be best for your treatment These CT scans are standard of care are used to make sure your treatment is being aimed properly and would be performed whether you are participating on this trial or not Once you are set up on the treatment table and are ready for radiation therapy the table will be turned around and the CT scan will be performed After the CT scan which should take about 5-8 minutes the table will be turned back around to the original position and the radiation treatment will be given to you In total about 30-33 CT scans will be performed for this study depending on the exact number of treatments the doctor decides would be best for your therapy
Routine MRI Scans
Routine MRI scans of your head and neck will be performed before treatment at Week 1 and after treatment sometime during Weeks 12-14 These scans may be used for routine treatment planning and checking the status of the disease
Study-Related MRI Scan
An additional MRI scan will be done halfway through treatment during Week 3 This MRI scan will be used to help researchers see if MRI scanning may be able to help doctors in the future to adjust someones treatment based on changes in a tumor its features and size in response to radiation In 15 participants a repeat baseline study-related MRI scan will be done 48 hours to 1 week following the first routine MRI scan
Modified Barium Swallow
Your swallowing function will be tested with a special type of x-ray called a modified barium swallow MBS During the test you will eat and drink foods and liquids mixed with a contrast chemical called barium that will make your throat more visible in the x-rays A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat
MBS will be performed before you start radiation therapy 4-6 months after the end of radiation therapy and during your routine follow-up visits 12 months plus or minus 2 months and 24 months plus or minus 3 months
Saliva Testing
One reason IMRT is being used is to try to protect your parotid glands the largest of the salivary glands from receiving too much radiation To check this a study-related saliva test will be done For this test the amount of saliva your parotid glands create will be measured before treatment within 7 days before Week 1 and at the last week of treatment during Week 6 or 7 Do not eat or drink anything or put anything in your mouth for 1 hour before the saliva collections You will be asked to let your saliva collect in your mouth for 5 minutes and then spit into a cup After that you will be given a mild citric acid solution like lemon juice to put in your mouth You will let the saliva collect in your mouth for 5 minutes and then spit in a cup Saliva testing will be performed under a separate protocol LAB07-0050
Length of Study
If the disease gets worse or intolerable side effects occur you will be taken off this study
Follow-Up Visits
At some time between Weeks 22 and 24 then every 3-4 months for up to 2 years after the last IMRT you will return for follow-up visits The amount of saliva your parotid glands create will be measured 6 weeks after radiation therapy 4-6 months after radiation therapy 1 year plus or minus 2 months after radiation therapy and 2 years plus or minus 3 months after radiation therapy
This is an investigational study The ExaCT machine is FDA approved for use in IMRT in patients with head and neck cancer Researchers are using this standard of care CT Scan for routine quality assurance to make sure your treatment is given correctly Up to 45 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02092 | REGISTRY | NCI CTRP | None |